Systems and methods for selecting stimulation parameters by targeting and steering

ABSTRACT

Methods and systems for selecting stimulation parameters using targeting and steering techniques are presented. For example, a method or system (via actions performed by a processor) can include receiving a name of an anatomical or physiological target or a name of a disease or disorder; receiving a clinical goal; and using at least 1) the anatomical or physiological target or disease or disorder and 2) the clinical goal, selecting a set of stimulation parameters. Another method or system (via actions performed by its processor) can include receiving a first set of stimulation parameters; receiving a command to alter the first set of stimulation parameters that does not include, or is not composed exclusively of, a numerical value for any of the stimulation parameters; and modifying the first set of stimulation parameters to create a second set of stimulation parameters based on the command.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(e) of U.S.Provisional Patent Application Ser. No. 62/186,172, filed Jun. 29, 2015,which is incorporated herein by reference.

FIELD

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to systems and methods for selectingstimulation parameters using targeting and steering mechanisms.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Peripheral nerve stimulation has been used totreat chronic pain syndrome and incontinence, with a number of otherapplications under investigation. Functional electrical stimulationsystems have been applied to restore some functionality to paralyzedextremities in spinal cord injury patients. Stimulation of the brain,such as deep brain stimulation, can be used to treat a variety ofdiseases or disorders.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (with a pulsegenerator), one or more leads, and an array of stimulator electrodes oneach lead. The stimulator electrodes are in contact with or near thenerves, muscles, or other tissue to be stimulated. The pulse generatorin the control module generates electrical pulses that are delivered bythe electrodes to body tissue.

BRIEF SUMMARY

One embodiment is a system for identifying a set of stimulationparameters, the system includes a computer processor configured andarranged to perform the following actions: receiving a name of ananatomical or physiological target or a name of a disease or disorder;receiving a clinical goal; and using at least 1) the anatomical orphysiological target or disease or disorder and 2) the clinical goal,selecting a set of stimulation parameters.

Another embodiment is a non-transitory computer-readable medium havingprocessor-executable instructions for identifying a set of stimulationparameters, the processor-executable instructions when installed onto adevice enable the device to perform actions, including: receiving a nameof an anatomical or physiological target or a name of a disease ordisorder; receiving a clinical goal; and using at least 1) theanatomical or physiological target or disease or disorder and 2) theclinical goal, selecting a set of stimulation parameters.

Yet another embodiment is a method for identifying a set of stimulationparameters. The method includes receiving a name of an anatomical orphysiological target or a name of a disease or disorder; receiving aclinical goal; and using at least 1) the anatomical or physiologicaltarget or disease or disorder and 2) the clinical goal, selecting a setof stimulation parameters.

In at least some embodiments, the system, non-transitorycomputer-readable medium, or method described above further includesreceiving a system goal, wherein selecting the set of stimulationparameters includes using the system goal to select the set ofstimulation parameters. In at least some embodiments of the system,non-transitory computer-readable medium, or method described above, thesystem goal refers to one or more components of an electricalstimulation system or to one or more stimulation parameters and alsorefers to an objective related to the one or more components orstimulation parameters.

In at least some embodiments of the system, non-transitorycomputer-readable medium, or method described above, the clinical goalrefers to the disease or disorder or to a symptom of the disease ordisorder or to an effect or side effect associated with the disease ordisorder or with electrical stimulation of the anatomical orphysiological target.

In at least some embodiments, the system, non-transitorycomputer-readable medium, or method described above further includesreceiving a user modification of at least one of the stimulationparameters. In at least some embodiments of the system, non-transitorycomputer-readable medium, or method described above, selecting the setof stimulation parameters further includes using previous stimulationinstances or estimated stimulation instances to select the set ofstimulation parameters. In at least some embodiments, the system,non-transitory computer-readable medium, or method described abovefurther includes displaying an estimated stimulation region based on theselected set of stimulation parameters.

A further embodiment is a system for identifying a set of stimulationparameters, the system includes a computer processor configured andarranged to perform the following actions: providing a model of a leadincluding a plurality of electrodes, wherein the plurality of electrodesincludes a plurality of segmented electrodes forming at least one set ofsegmented electrodes, wherein each set of segmented electrodes includesa plurality of the segmented electrodes disposed around a circumferenceof the lead at a same longitudinal position along the lead; receiving aselection of a target point external to the lead; projecting the targetpoint onto a surface of the lead to identify a virtual electrode; andselecting a set of stimulation parameters for at least one of theelectrodes to approximate an electrical field generated from the virtualelectrode.

Another embodiment is a non-transitory computer-readable medium havingprocessor-executable instructions for identifying a set of stimulationparameters, the processor-executable instructions when installed onto adevice enable the device to perform actions, including: providing amodel of a lead including a plurality of electrodes, wherein theplurality of electrodes includes a plurality of segmented electrodesforming at least one set of segmented electrodes, wherein each set ofsegmented electrodes includes a plurality of the segmented electrodesdisposed around a circumference of the lead at a same longitudinalposition along the lead; receiving a selection of a target pointexternal to the lead; projecting the target point onto a surface of thelead to identify a virtual electrode; and selecting a set of stimulationparameters for at least one of the electrodes to approximate anelectrical field generated from the virtual electrode.

Yet another embodiment is a method for identifying a set of stimulationparameters. The method includes providing a model of a lead including aplurality of electrodes, wherein the plurality of electrodes includes aplurality of segmented electrodes forming at least one set of segmentedelectrodes, wherein each set of segmented electrodes includes aplurality of the segmented electrodes disposed around a circumference ofthe lead at a same longitudinal position along the lead; receiving aselection of a target point external to the lead; projecting the targetpoint onto a surface of the lead to identify a virtual electrode; andselecting a set of stimulation parameters for at least one of theelectrodes to approximate an electrical field generated from the virtualelectrode.

In at least some embodiments of the system, non-transitorycomputer-readable medium, or method described above, projecting thetarget point includes projecting the target point onto a nearest pointof the surface of the lead to identify the virtual electrode. In atleast some embodiments, the system, non-transitory computer-readablemedium, or method described above further includes calculating theelectrical field in a region that does not overlap with the lead and isbounded by a plane tangent to the lead at the virtual electrode. In atleast some embodiments of the system, non-transitory computer-readablemedium, or method described above, the electrical field is a scalarpotential field, a vector field, or a field of Hamiltonians of adivergence of an electrical field.

In at least some embodiments, the system, non-transitorycomputer-readable medium, or method described above further includesreceiving a user modification of at least one of the stimulationparameters. In at least some embodiments, the system, non-transitorycomputer-readable medium, or method described above, further includesdefining at least one guarding electrode adjacent the virtual electrode.In at least some embodiments of the system, non-transitorycomputer-readable medium, or method described above, defining at leastone guarding electrode includes defining two guarding electrodescircumferentially disposed on opposite sides of the virtual electrode.

A further embodiment is a system for identifying a set of stimulationparameters, the system includes a computer processor configured andarranged to perform the following actions: receiving a first set ofstimulation parameters; receiving a command to alter the first set ofstimulation parameters, wherein the command does not include, or is notcomposed exclusively of, a numerical value for any of the stimulationparameters; and modifying the first set of stimulation parameters tocreate a second set of stimulation parameters based on the command.

Another embodiment is a non-transitory computer-readable medium havingprocessor-executable instructions for identifying a set of stimulationparameters, the processor-executable instructions when installed onto adevice enable the device to perform actions, including: receiving afirst set of stimulation parameters; receiving a command to alter thefirst set of stimulation parameters, wherein the command does notinclude, or is not composed exclusively of, a numerical value for any ofthe stimulation parameters; and modifying the first set of stimulationparameters to create a second set of stimulation parameters based on thecommand.

Yet another embodiment is a method for identifying a set of stimulationparameters. The method includes receiving a first set of stimulationparameters; receiving a command to alter the first set of stimulationparameters, wherein the command does not include, or is not composedexclusively of, a numerical value for any of the stimulation parameters;and modifying the first set of stimulation parameters to create a secondset of stimulation parameters based on the command.

In at least some embodiments, the system, non-transitorycomputer-readable medium, or method described above further includesdisplaying an estimated stimulation region based on the first set ofstimulation parameters. In at least some embodiments, the system,non-transitory computer-readable medium, or method described abovefurther includes, upon modification of the first set of stimulationparameters to create the second set of stimulation parameters, modifyingthe display to display an estimated stimulation region based on thesecond set of stimulation parameters.

In at least some embodiments, the system, non-transitorycomputer-readable medium, or method described above further includesreceiving a user modification of at least one of the stimulationparameters of the second set of stimulation parameters. In at least someembodiments, the system, non-transitory computer-readable medium, ormethod described above further includes repeating the actions with thesecond set of stimulation parameters becoming the first set ofstimulation parameters for the repeated actions. In at least someembodiments, the system, non-transitory computer-readable medium, ormethod described above further includes sending the second set ofstimulation parameters to an implantable pulse generator of anelectrical stimulation system.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of an electricalstimulation system, according to the invention;

FIG. 2 is a schematic side view of one embodiment of an electricalstimulation lead, according to the invention;

FIG. 3 is a schematic block diagram of one embodiment of a system fordetermining stimulation parameters, according to the invention;

FIG. 4 is a flowchart of one embodiment of a method of determiningstimulation parameters, according to the invention;

FIG. 5 is a flowchart of a second embodiment of a method of determiningstimulation parameters, according to the invention;

FIG. 6A is a diagrammatic illustration of one embodiment of a method ofselecting a stimulation target, according to the invention;

FIG. 6B is a diagrammatic illustration of the embodiment of FIG. 6Arotated to view along a plane including line 610, according to theinvention;

FIG. 7 is a flowchart of a third embodiment of a method of determiningstimulation parameters, according to the invention;

FIG. 8 is a flowchart of a fourth embodiment of a method of determiningstimulation parameters, according to the invention;

FIG. 9A is a diagrammatic illustration of one embodiment of a method ofselecting a point source, according to the invention;

FIG. 9B is a diagrammatic illustration of the embodiment of FIG. 9Ataken from an orthogonal position, according to the invention;

FIG. 10 is a diagrammatic illustration of an electrical field calculatedfor the point source of FIG. 9A, according to the invention;

FIG. 11 is a diagrammatic illustration of a portion of a model of a leadand a virtual electrode defined for the lead, according to theinvention; and

FIG. 12 is a diagrammatic illustration of a cross-section of the lead ofFIG. 11 illustrating the virtual electrode and a guarding electrode,according to the invention.

DETAILED DESCRIPTION

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to systems and methods for selectingstimulation parameters using targeting and steering mechanisms.

Suitable implantable electrical stimulation systems include, but are notlimited to, a least one lead with one or more electrodes disposed on adistal end of the lead and one or more terminals disposed on one or moreproximal ends of the lead. Leads include, for example, percutaneousleads, paddle leads, cuff leads, or any other arrangement of electrodeson a lead. Examples of electrical stimulation systems with leads arefound in, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029;6,609,032; 6,741,892; 7,244,150; 7,450,997; 7,672,734; 7,761,165;7,783,359; 7,792,590; 7,809,446; 7,949,395; 7,974,706; 8,175,710;8,224,450; 8,271,094; 8,295,944; 8,364,278; 8,391,985; and 8,688,235;and U.S. Patent Applications Publication Nos. 2007/0150036;2009/0187222; 2009/0276021; 2010/0076535; 2010/0268298; 2011/0005069;2011/0004267; 2011/0078900; 2011/0130817; 2011/0130818; 2011/0238129;2011/0313500; 2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911;2012/0197375; 2012/0203316; 2012/0203320; 2012/0203321; 2012/0316615;2013/0105071; and 2013/0197602, all of which are incorporated byreference. In the discussion below, a percutaneous lead will beexemplified, but it will be understood that the methods and systemsdescribed herein are also applicable to paddle leads and other leads.

A percutaneous lead for electrical stimulation (for example, deep brainor spinal cord stimulation) includes stimulation electrodes that can bering electrodes, segmented electrodes that extend only partially aroundthe circumference of the lead, or any other type of electrode, or anycombination thereof. The segmented electrodes can be provided in sets ofelectrodes, with each set having electrodes circumferentiallydistributed about the lead at a particular longitudinal position. Forillustrative purposes, the leads are described herein relative to usefor deep brain stimulation, but it will be understood that any of theleads can be used for applications other than deep brain stimulation,including spinal cord stimulation, peripheral nerve stimulation, orstimulation of other nerves, muscles, and tissues.

Turning to FIG. 1, one embodiment of an electrical stimulation system 10includes one or more stimulation leads 12 and an implantable pulsegenerator (IPG) 14. The system 10 can also include one or more of anexternal remote control (RC) 16, a clinician's programmer (CP) 18, anexternal trial stimulator (ETS) 20, or an external charger 22.

The IPG 14 is physically connected, optionally via one or more leadextensions 24, to the stimulation lead(s) 12. Each lead carries multipleelectrodes 26 arranged in an array. The IPG 14 includes pulse generationcircuitry that delivers electrical stimulation energy in the form of,for example, a pulsed electrical waveform (i.e., a temporal series ofelectrical pulses) to the electrode array 26 in accordance with a set ofstimulation parameters. The implantable pulse generator can be implantedinto a patient's body, for example, below the patient's clavicle area orwithin the patient's buttocks or abdominal cavity. The implantable pulsegenerator can have eight stimulation channels which may be independentlyprogrammable to control the magnitude of the current stimulus from eachchannel. In some embodiments, the implantable pulse generator can havemore or fewer than eight stimulation channels (e.g., 4-, 6-, 16-, 32-,or more stimulation channels). The implantable pulse generator can haveone, two, three, four, or more connector ports, for receiving theterminals of the leads.

The ETS 20 may also be physically connected, optionally via thepercutaneous lead extensions 28 and external cable 30, to thestimulation leads 12. The ETS 20, which may have similar pulsegeneration circuitry as the IPG 14, also delivers electrical stimulationenergy in the form of, for example, a pulsed electrical waveform to theelectrode array 26 in accordance with a set of stimulation parameters.One difference between the ETS 20 and the IPG 14 is that the ETS 20 isoften a non-implantable device that is used on a trial basis after theneurostimulation leads 12 have been implanted and prior to implantationof the IPG 14, to test the responsiveness of the stimulation that is tobe provided. Any functions described herein with respect to the IPG 14can likewise be performed with respect to the ETS 20.

The RC 16 may be used to telemetrically communicate with or control theIPG 14 or ETS 20 via a uni- or bi-directional wireless communicationslink 32. Once the IPG 14 and neurostimulation leads 12 are implanted,the RC 16 may be used to telemetrically communicate with or control theIPG 14 via a uni- or bi-directional communications link 34. Suchcommunication or control allows the IPG 14 to be turned on or off and tobe programmed with different stimulation parameter sets. The IPG 14 mayalso be operated to modify the programmed stimulation parameters toactively control the characteristics of the electrical stimulationenergy output by the IPG 14. The CP 18 allows a user, such as aclinician, the ability to program stimulation parameters for the IPG 14and ETS 20 in the operating room and in follow-up sessions.

The CP 18 may perform this function by indirectly communicating with theIPG 14 or ETS 20, through the RC 16, via a wireless communications link36. Alternatively, the CP 18 may directly communicate with the IPG 14 orETS 20 via a wireless communications link (not shown). The stimulationparameters provided by the CP 18 are also used to program the RC 16, sothat the stimulation parameters can be subsequently modified byoperation of the RC 16 in a stand-alone mode (i.e., without theassistance of the CP 18).

For purposes of brevity, the details of the RC 16, CP 18, ETS 20, andexternal charger 22 will not be further described herein. Details ofexemplary embodiments of these devices are disclosed in U.S. Pat. No.6,895,280, which is expressly incorporated herein by reference. Otherexamples of electrical stimulation systems can be found at U.S. Pat.Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,949,395;7,244,150; 7,672,734; and U.S. Pat. Nos. 7,761,165; 7,974,706;8,175,710; 8,224,450; and 8,364,278; and U.S. Patent ApplicationPublication No. 2007/0150036, as well as the other references citedabove, all of which are incorporated by reference.

FIG. 2 illustrates one embodiment of a lead 110 with electrodes 125disposed at least partially about a circumference of the lead 110 alonga distal end portion of the lead and terminals 135 disposed along aproximal end portion of the lead. The lead 110 can be implanted near orwithin the desired portion of the body to be stimulated such as, forexample, the brain, spinal cord, or other body organs or tissues. In oneexample of operation for deep brain stimulation, access to the desiredposition in the brain can be accomplished by drilling a hole in thepatient's skull or cranium with a cranial drill (commonly referred to asa burr), and coagulating and incising the dura mater, or brain covering.The lead 110 can be inserted into the cranium and brain tissue with theassistance of a stylet (not shown). The lead 110 can be guided to thetarget location within the brain using, for example, a stereotacticframe and a microdrive motor system. In some embodiments, the microdrivemotor system can be fully or partially automatic. The microdrive motorsystem may be configured to perform one or more the following actions(alone or in combination): insert the lead 110, advance the lead 110,retract the lead 110, or rotate the lead 110.

In some embodiments, measurement devices coupled to the muscles or othertissues stimulated by the target neurons, or a unit responsive to thepatient or clinician, can be coupled to the implantable pulse generatoror microdrive motor system. The measurement device, user, or cliniciancan indicate a response by the target muscles or other tissues to thestimulation or recording electrode(s) to further identify the targetneurons and facilitate positioning of the stimulation electrode(s). Forexample, if the target neurons are directed to a muscle experiencingtremors, a measurement device can be used to observe the muscle andindicate changes in, for example, tremor frequency or amplitude inresponse to stimulation of neurons. Alternatively, the patient orclinician can observe the muscle and provide feedback.

The lead 110 for deep brain stimulation can include stimulationelectrodes, recording electrodes, or both. In at least some embodiments,the lead 110 is rotatable so that the stimulation electrodes can bealigned with the target neurons after the neurons have been locatedusing the recording electrodes.

Stimulation electrodes may be disposed on the circumference of the lead110 to stimulate the target neurons. Stimulation electrodes may bering-shaped so that current projects from each electrode equally inevery direction from the position of the electrode along a length of thelead 110. In the embodiment of FIG. 2, two of the electrodes 120 arering electrodes 120. Ring electrodes typically do not enable stimuluscurrent to be directed from only a limited angular range around of thelead. Segmented electrodes 130, however, can be used to direct stimuluscurrent to a selected angular range around the lead. When segmentedelectrodes are used in conjunction with an implantable pulse generatorthat delivers constant current stimulus, current steering can beachieved to more precisely deliver the stimulus to a position around anaxis of the lead (i.e., radial positioning around the axis of the lead).To achieve current steering, segmented electrodes can be utilized inaddition to, or as an alternative to, ring electrodes.

The lead 100 includes a lead body 110, terminals 135, and one or morering electrodes 120 and one or more sets of segmented electrodes 130 (orany other combination of electrodes). The lead body 110 can be formed ofa biocompatible, non-conducting material such as, for example, apolymeric material. Suitable polymeric materials include, but are notlimited to, silicone, polyurethane, polyurea, polyurethane-urea,polyethylene, or the like. Once implanted in the body, the lead 100 maybe in contact with body tissue for extended periods of time. In at leastsome embodiments, the lead 100 has a cross-sectional diameter of no morethan 1.5 mm and may be in the range of 0.5 to 1.5 mm. In at least someembodiments, the lead 100 has a length of at least 10 cm and the lengthof the lead 100 may be in the range of 10 to 70 cm.

The electrodes 125 can be made using a metal, alloy, conductive oxide,or any other suitable conductive biocompatible material. Examples ofsuitable materials include, but are not limited to, platinum, platinumiridium alloy, iridium, titanium, tungsten, palladium, palladiumrhodium, or the like. Preferably, the electrodes are made of a materialthat is biocompatible and does not substantially corrode under expectedoperating conditions in the operating environment for the expectedduration of use.

Each of the electrodes can either be used or unused (OFF). When theelectrode is used, the electrode can be used as an anode or cathode andcarry anodic or cathodic current. In some instances, an electrode mightbe an anode for a period of time and a cathode for a period of time.

Deep brain stimulation leads may include one or more sets of segmentedelectrodes. Segmented electrodes may provide for superior currentsteering than ring electrodes because target structures in deep brainstimulation are not typically symmetric about the axis of the distalelectrode array. Instead, a target may be located on one side of a planerunning through the axis of the lead. Through the use of a radiallysegmented electrode array (“RSEA”), current steering can be performednot only along a length of the lead but also around a circumference ofthe lead. This provides precise three-dimensional targeting and deliveryof the current stimulus to neural target tissue, while potentiallyavoiding stimulation of other tissue. Examples of leads with segmentedelectrodes include U.S. Pat. Nos. 8,473,061; 8,571,665; and 8,792,993;U.S. Patent Application Publications Nos. 2010/0268298; 2011/0005069;2011/0130803; 2011/0130816; 2011/0130817; 2011/0130818; 2011/0078900;2011/0238129; 2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911;2012/197375; 2012/0203316; 2012/0203320; 2012/0203321; 2013/0197424;2013/0197602; 2014/0039587; 2014/0353001; 2014/0358208; 2014/0358209;2014/0358210; 2015/0045864; 2015/0066120; 2015/0018915; 2015/0051681;U.S. patent application Ser. Nos. 14/557,211 and 14/286,797; and U.S.Provisional Patent Application Ser. No. 62/113,291, all of which areincorporated herein by reference.

An electrical stimulation lead can be implanted in the body of a patient(for example, in the brain or spinal cord of the patient) and used tostimulate surrounding tissue. In at least some embodiments, it is usefulto estimate the effective region of stimulation (often called a volumeof activation (VOA) or stimulation field model (SFM)) given the positionof the lead and its electrodes in the patient's body and the stimulationparameters used to generate the stimulation. Any suitable method fordetermining the VOA/SFM and for graphically displaying the VOA/SFMrelative to patient anatomy can be used including those described in,for example, U.S. Pat. Nos. 8,326,433; 8,675,945; 8,831,731; 8,849,632;and 8,958,615; U.S. Patent Application Publications Nos. 2009/0287272;2009/0287273; 2012/0314924; 2013/0116744; 2014/0122379; and2015/0066111; and U.S. Provisional Patent Application Ser. No.62/030,655, all of which are incorporated herein by reference. Severalof these references also discloses methods and systems for registeringan atlas of body structures to imaged patient physiology.

In conventional systems, a VOA is determined based on a set ofstimulation parameters input into the system. The VOA can then bemodified by the user by modifying the stimulation parameters anddetermining the new VOA from the modified stimulation parameters. Thisallows the user to tailor the stimulation volume.

In contrast to these conventional systems which determine the VOA fromuser-selected stimulation parameters, in at least some embodiments, thepresent systems or methods allow the user to define the target that isdesired for stimulation and then the systems or methods determine a setof stimulation parameters based on that target. There are a number ofdifferent methods for selecting a desired stimulation target describedbelow. In some embodiments, the user selects the volume directly. Inother embodiments, the user selects the target indirectly by indicatingan anatomical structure, disease or disorder, clinical goal, or systemgoal, or any combination thereof.

FIG. 3 illustrates one embodiment of a system for practicing theinvention. The system can include a computing device 300 or any othersimilar device that includes a processor 302 and a memory 304, a display306, an input device 308, and, optionally, the electrical stimulationsystem 312. The system 300 may also optionally include one or moreimaging systems 310.

The computing device 300 can be a computer, tablet, mobile device, orany other suitable device for processing information. The computingdevice 300 can be local to the user or can include components that arenon-local to the computer including one or both of the processor 302 ormemory 304 (or portions thereof). For example, in some embodiments, theuser may operate a terminal that is connected to a non-local computingdevice. In other embodiments, the memory can be non-local to the user.

The computing device 300 can utilize any suitable processor 302including one or more hardware processors that may be local to the useror non-local to the user or other components of the computing device.The processor 302 is configured to execute instructions provided to theprocessor, as described below.

Any suitable memory 304 can be used for the computing device 302. Thememory 304 illustrates a type of computer-readable media, namelycomputer-readable storage media. Computer-readable storage media mayinclude, but is not limited to, nonvolatile, non-transitory, removable,and non-removable media implemented in any method or technology forstorage of information, such as computer readable instructions, datastructures, program modules, or other data. Examples ofcomputer-readable storage media include RAM, ROM, EEPROM, flash memory,or other memory technology, CD-ROM, digital versatile disks (“DVD”) orother optical storage, magnetic cassettes, magnetic tape, magnetic diskstorage or other magnetic storage devices, or any other medium which canbe used to store the desired information and which can be accessed by acomputing device.

Communication methods provide another type of computer readable media;namely communication media. Communication media typically embodiescomputer-readable instructions, data structures, program modules, orother data in a modulated data signal such as a carrier wave, datasignal, or other transport mechanism and include any informationdelivery media. The terms “modulated data signal,” and “carrier-wavesignal” includes a signal that has one or more of its characteristicsset or changed in such a manner as to encode information, instructions,data, and the like, in the signal. By way of example, communicationmedia includes wired media such as twisted pair, coaxial cable, fiberoptics, wave guides, and other wired media and wireless media such asacoustic, RF, infrared, and other wireless media.

The display 306 can be any suitable display device, such as a monitor,screen, display, or the like, and can include a printer. The inputdevice 308 can be, for example, a keyboard, mouse, touch screen, trackball, joystick, voice recognition system, or any combination thereof, orthe like.

One or more imaging systems 310 can be used including, but not limitedto, MRI, CT, ultrasound, or other imaging systems. The imaging system310 may communicate through a wired or wireless connection with thecomputing device 300 or, alternatively or additionally, a user canprovide images from the imaging system 310 using a computer-readablemedium or by some other mechanism.

The electrical stimulation system 312 can include, for example, any ofthe components illustrated in FIG. 1. The electrical stimulation system312 may communicate with the computing device 300 through a wired orwireless connection or, alternatively or additionally, a user canprovide information between the electrical stimulation system 312 andthe computing device 300 using a computer-readable medium or by someother mechanism. In some embodiments, the computing device 300 mayinclude part of the electrical stimulation system, such as, for example,the IPG, CP, RC, ETS, or any combination thereof.

The methods and systems described herein may be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein. Accordingly, the methods and systemsdescribed herein may take the form of an entirely hardware embodiment,an entirely software embodiment or an embodiment combining software andhardware aspects. Systems referenced herein typically include memory andtypically include methods for communication with other devices includingmobile devices. Methods of communication can include both wired andwireless (e.g., RF, optical, or infrared) communications methods andsuch methods provide another type of computer readable media; namelycommunication media. Wired communication can include communication overa twisted pair, coaxial cable, fiber optics, wave guides, or the like,or any combination thereof. Wireless communication can include RF,infrared, acoustic, near field communication, Bluetooth™, or the like,or any combination thereof.

Programming an electrical stimulation (for example, a deep brainstimulation (DBS) or spinal cord stimulation (SCS)) system hasconventionally involved significant time spent by a variety ofprogramming experts, having varying levels of training and experience,with those programmers subscribing to various schools of thoughtregarding the choice of stimulation parameters. A preferred programmingsolution would offer tools to users or programmers to program morequickly, to more often arrive at efficacious sets of stimulationparameters, and to increase the efficacy of the patient's therapy.

In at least some embodiments, two different tasks can be identified:Targeting and Steering. Targeting can refer to, for example, anautomated or semi-automated selection of a set of stimulation parametersbased on any number or type of data or criteria. Steering (for example,current steering) can refer to the automated or semi-automated selectionof sets of stimulation parameters resulting in stepwise changes tostimulation, again based on any number of type of data or criteria. Inat least some embodiments, targeting can be the selection of a final setof stimulation parameters which achieve a desired stimulation goal, andsteering can be a method of exploring the stimulation parameter spaceusing, for example, abstracted controls.

In one embodiment of a method of selecting stimulation parameters (e.g.,targeting), the user employs alphanumeric descriptors, instead of visualor graphical views, to describe the objective of the electricalstimulation therapy. The system can use these alphanumeric descriptors,as well as data from actual or estimated stimulation instances, toselect at least one set of stimulation parameters to achieve thedescribed objective. In at least some embodiments, no graphical viewsare presented to the user. In at least some embodiments, no imaging datais required. In some other embodiments, imaging data related to surgicalplacement of the lead or imaging data of the anatomical structures inwhich the lead is (or is to be) placed, or graphical data relating tophysiological structures or responses to stimulation mapped to 3D oranatomical space or a common space, such as MNI space, or anycombination thereof may optionally be provided.

FIG. 4 illustrates a flowchart of one method of selecting stimulationparameters using alphanumeric descriptors. In step 402, the userprovides the name of an anatomical or physiological target. Examples ofsuch targets include, but are not limited to, the subthalamic nucleus(STN), internal segment of the globus pallidus (GPi), external segmentof the globus pallidus (GPe), and the like. In at least someembodiments, an anatomical structure is defined by its physicalstructure and a physiological target is defined by its functionalattributes. The user may input the name of the anatomical orphysiological target using a keyboard, touchscreen, voice-recognitionsystem, or any other suitable input device. Additionally oralternatively, the user may select the anatomical or physiologicaltarget from a list using, for example, a drop-down menu or any othersuitable selection mechanism. In some embodiments, there can be morethan one anatomical or physiological target provided.

In step 404, the user provides the name of a disease or disorder (e.g.Parkinson's disease, depression, epilepsy) that is to be treated. Insome instances, the disease or disorder may be a symptom or conditionassociated with another disease or disorder. The user may input the nameof the disease or disorder using a keyboard, touchscreen,voice-recognition system, or any other suitable input device.Additionally or alternatively, the user may select the disease ordisorder from a list using, for example, a drop-down menu or any othersuitable selection mechanism. In some embodiments, the system maypresent a list for the disease or disorder based on the previouslyprovided anatomical or physiological target. In some embodiments, therecan be more than one disease or disorder provided. In some embodiments,step 402 is skipped and the user-provided name from step 404 is utilizedby the system to select a target (which can be an anatomical orphysiological target) or to present a list of targets to the user.

In step 406, the user provides a clinical goal. In at least someembodiments, the clinical goal may be input as a verb/noun combination,for example, ‘reduce’+‘tremor’ or ‘avoid’+‘cognitive impairment’. Theclinical goal generally refers the disease or disorder or to a symptomof the disease or disorder or to an effect or side effect associatedwith the disease or disorder or with electrical stimulation of theanatomical or physiological target. The user may input the clinical goalusing a keyboard, touchscreen, voice-recognition system, or any othersuitable input device. Additionally or alternatively, the user mayselect the clinical goal from a list using, for example, a drop-downmenu or any other suitable selection mechanism. In some embodiments, thesystem may present a list for the clinical goal based on the previouslyprovided anatomical or physiological target or provided disease ordisorder or both. In some embodiments, there can be more than oneclinical goal provided. In some embodiments, one or more clinical goalscan be suggested by the system based on selections made in steps 402,404, or 408.

In optional step 408, the user can provide a system goal, such as, forexample, ‘extended battery life’, ‘low frequency’, ‘short pulse width’,or the like. The system goal generally refers to one or more of thecomponents of the stimulation system or to one or more of thestimulation parameters and indicates an objective related to thecomponent or parameter. The user may input the system goal using akeyboard, touchscreen, voice-recognition system, or any other suitableinput device. Additionally or alternatively, the user may select thesystem goal from a list using, for example, a drop-down menu or anyother suitable selection mechanism. In some embodiments, there can bemore than one system goal provided. In some embodiments, one or moresystem goals can be suggested by the system based on selections made insteps 402, 404, or 406.

It will be understood that steps 402, 404, 406, and 408 can berearranged in any order. In step 410, the system uses the providedinputs from steps 402, 404, 406, and 408 to select a set of stimulationparameters. In at least some embodiments, the system can utilizeprevious actual or estimated stimulation instances to correlate with theselections or inputs made by the user. For example, the anatomical orphysiological target and, optionally, the disease or disorder andclinical goal, may be used to identify a target region for stimulation.In some embodiments, the anatomical or physiological target, disease ordisorder, clinical goal, or system goal (or any combination thereof) mayprovide limits (for example, ranges, maximum values, or minimum values,or sets of combinations of parameters) for one or more stimulationparameters. Examples of methods to determine stimulation parameters aredescribed in more detail below.

FIG. 5 illustrates another method for selecting stimulation parameters.In step 502, a graphical user interface (GUI) is presented with one ormore views containing a two-dimension (2D) or three-dimensional (3D)representation of the lead or leads present, as well as optionalanatomical structure or structures. The views may also contain notionalviews of programming parameters space, including or excluding displaysof responses to stimulation from the existing patient, prior patients,or populations of patients For a 3D representation, elements displayedmay be displayed as a 2D view into a 3D space, or using 3D technology(e.g. active displays, active glasses, passive glasses, holograms,haptic feedback ‘display’). Patient-specific imaging data may optionallybe provided (e.g. pre-operative MRI/CT, intra-operative MRI/CT,post-operative MRI/CT, or the like or any combination thereof).

In step 504, the user selects at least one target. In some embodiments,the user selects at least one anatomical target. For example, the usercan select an anatomical target that is shown on a display using anysuitable selection device, such as a touchscreen, mouse, touchpad, trackball, or the like, or the user can select an anatomical target from adrop-down menu or the like or the user can utilize any other suitableselection mechanism.

In other embodiments, the user can select at least one target volume,which is not a specific anatomical structure, but may include parts ofone or more anatomical structures. The target volume may be displayed inthe one or more views of the GUI. In at least some embodiments, thetarget volume can be drawn or otherwise indicated by the user. In atleast some embodiments, a sample target volume can be displayed and theuser can manipulate the sample target volume by, for example, changingboundaries of the sample target volume, changing a diameter of thesample target volume, or the like. In at least some embodiments, thetarget volume can be estimated based on, for example, a selection ofdisease state, surgical target, an auto-segmentation method, or the likeand then, at least in some instances, optionally modified by the user.

Methods for selecting a target are illustrated using FIGS. 6A and 6B.FIG. 6A illustrates diagrammatically one embodiment of a view 600 into a3D space. The lead 602 and its electrodes 634 (FIG. 6B) are illustratedin the center of the view. The ellipse signifies a target 603, such asan anatomical or physiological target. In this case, the lead 602 hasbeen positioned at least partially within the target 603, but in otherembodiments, the lead may be near, but not inside, the target. Thetarget 603 may have been selected using patient imaging data (e.g. MRI)or an atlas (a patient specific, probabilistic, or general atlas), orthe user may have drawn the target. The view also includes an axisindicator 605, which shows the orientation of different views into thespace.

In some embodiments, a target point 607 can be selected. In someembodiments, the target 603 or target point 607 is automatically placedby the system (using, for example, the input described above withrespect to FIG. 4) or the target 603 is automatically placed with someuser input (for example, if the user can move or otherwise select atarget point 607). In other embodiments, the target 603 is placedentirely by the user. In some embodiments, using the target point 607, atarget volume can be determined. For example, the selection of aparticular target point 607 can be used to result in the selection of alarger target 603 based on, for example, anatomical or physiologicalinformation. For example, a target point placed in a region of the STNmay result in the automatic selection of the entire STN as the target.

A dashed line 610 in FIG. 6A shows the location of a cutaway plane forthe view illustrated in FIG. 6B. FIGS. 6A and 6B may show two views intoa single viewport at different times, or two views shown in twodifferent viewports to the user at the same time. In some embodiments,the user can graphically or otherwise manipulate the views, such as, forexample, sliding or otherwise moving the cut plane in FIG. 6A to alterthe image shown in FIG. 6B.

In at least some embodiments, one or more targets 603 can be identifiedby the user. These targets 603 may be constructed using the GUI. Atarget 603 may be constructed entirely from scratch, or by using a setof primitives (for example, lines, spheres, cubes, rectangles, circles,triangles, or the like or any combination thereof), or in a stepwisefashion by modifying an initial target. For example, a user may place asphere primitive in the space, and then modulate its radius ortransition it to an ellipsoid with two axes. Targets may be combined asa union or an intersection to form final targets. Targets may beconstructed out of a series of outlines in various planes. For example,the user may draw an outline on each of three orthogonal planes (e.g.first the xy plane, then the yz plane, then the xz plane.)

Returning to FIG. 5, in optional step 506, a type of neurostimulationintervention is selected for one or more of the targets. Types ofneurostimulation intervention can include, for example, stimulation(application of a stimulating field or drug), activation (actuatingneurological tissue), depression (reducing the likelihood of activationof the neurological tissue), silencing (preventing the activation of theneurological tissue), or other forms of neuromodulation. Multiple formsof neuromodulation as described previously may be used in variouscombinations, with varying temporal order or relation, on the sametarget or targets. The intervention can be accomplished using electricalstimulation, optical stimulation, drug stimulation, or the like or anycombination thereof. The one or more targets may be selected withrespect to the desired type of intervention, for example, one or moretargets can be selected for activation, one or more targets fordepression, and one or more targets for silencing, or any combinationthereof. When multiple targets are identified, the targets may beselected for the same type of intervention or different targets may beselected for different types of intervention.

In at least some embodiments, the user indicates a type of neurologicalintervention for each target. In some embodiments, a default type ofneurological intervention (for example, stimulation or activation) isassumed unless the user selects a different type of neurologicalintervention. In some embodiments, the user can select the type ofneurological intervention from a pull-down menu, optionally associatedor displayed on the target, or by any other selection technique.

In optional step 508, the user provides the name of a disease ordisorder (e.g. Parkinson's disease, depression, epilepsy) that is to betreated. In some instances, the disease or disorder may be a symptom orcondition associated with another disease or disorder. The user mayinput the name of the disease or disorder using a keyboard, touchscreen,voice-recognition system, or any other suitable input device.Additionally or alternatively, the user may select the disease ordisorder from a list using, for example, a drop-down menu or any othersuitable selection mechanism. In some embodiments, the system maypresent a list for the disease or disorder based on the previouslyprovided target. In some embodiments, there can be more than one diseaseor disorder provided.

In optional step 510, the user provides a clinical goal or a system goalor any combination thereof. In at least some embodiments, the clinicalgoal may be input as a verb/noun combination, for example,‘reduce’+‘tremor’ or ‘avoid’+‘cognitive impairment’. The clinical goalgenerally refers to a disease or disorder or to a symptom of the diseaseor disorder or to a side-effect associated with the disease, disorder,or stimulation. The system goal generally refers to one or more of thecomponents of the stimulation system or to one or more of thestimulation parameters and indicates an objection related to thecomponent or parameter, such as, for example, ‘extended battery life’,‘low frequency’, ‘short pulse width’, or the like. The user may inputthe clinical or system goal using a keyboard, touchscreen,voice-recognition system, or any other suitable input device.Additionally or alternatively, the user may select the clinical orsystem goal from a list using, for example, a drop-down menu or anyother suitable selection mechanism. In some embodiments, the system maypresent a list for the clinical or system goal based on the previouslyprovided target or provided disease or disorder or both. In someembodiments, there can be more than one clinical or system goalprovided.

It will be understood that steps 504, 506, 508, or 510 can be rearrangedin any order. In step 512, the system uses the provided inputs fromsteps 504, 506, 508, or 510 to select a set of stimulation parameters.In at least some embodiments, the system can utilize previous actual orestimated stimulation instances to correlate with the selections orinputs made by the user.

When selecting stimulation parameters, for example, according to step410 in FIG. 4 of step 512 in FIG. 5, individual parameters may belimited based on one or more considerations, such as, for example, theanatomical structures that are targeted or on the disease or disorderbeing treated (or any combination thereof). For example, if the chosentarget volume includes the STN, optionally with Parkinson's disease (PD)or essential tremor (ET) as an indication, the system may identify arange of pulse rates (e.g. 60-10,000 Hz), or a range of pulse widths(e.g. 30-90 μs). These limits may be a range limit, a maximum limit, aminimum limit, a set of allowed parameter combinations, or the like. Inan alternative or combined manner, the user may prescribe or modify oneor more settings, for example, pulse width, rate, pulse regularity,waveform shape, pulse train information, spatio-temporal patterns, orthe like.

Any suitable method can be used to select stimulation parametersincluding methods disclosed in copending U.S. Provisional PatentApplication Ser. No. 62/186,184, entitled “Systems and Methods forAnalyzing Electrical Stimulation and Selecting or Manipulating Volumesof Activation”, filed on even date herewith. The anatomical region thatis stimulated for a particular set of stimulation parameters can beestimated using any suitable estimation technique. These estimates caninclude, for example, estimates of axonal activation, estimates of cellbodies that are activated, estimates of fiber pathways that areactivated, and the like or any combination thereof. In at least someinstances, the estimate is called a value of activation (VOA) orstimulation field model (SFM) Examples of suitable methods for makingthese estimations include, but are not limited to, those described inU.S. Pat. Nos. 8,326,433; 8,675,945; 8,831,731; 8,849,632; and8,958,615; U.S. Patent Application Publications Nos. 2009/0287272;2009/0287273; 2012/0314924; 2013/0116744; 2014/0122379; and2015/0066111; and U.S. Provisional Patent Application Ser. No.62/030,655, all of which are incorporated herein by reference. It willbe understood that other methods of estimating the stimulation regionthat do not use the stimulation parameters can also be employed.

The estimated stimulation region can be compared to the target todetermine correspondence to the target. In at least some embodiments,the system or user can set a threshold (for example, a percentageoverlap between the estimated stimulation region and the target or apercentage difference between the target and the estimate stimulationregion) which when met by the comparison indicates that a set ofstimulation parameters can be accepted as a final set of stimulationparameters. In some embodiments, a set of stimulation parameters can bearrived at iteratively based on the comparison and subsequentmodification of the stimulation parameters. Such an iterative processcan be performed automatically by a processor or performedsemi-automatically with occasional input from the user or can beperformed with user input to direct which parameters to modify or theamount of the modifications. In other embodiments, a system may comparea target with previously determined estimations (for example, a set ofpreviously calculated VOAs or SFMs) and select a set of parameters basedon these comparisons.

In at least some embodiments, the set of stimulation parameters mayinclude one or more subsets of stimulation parameters to provide aneuromodulation intervention for more than one (overlapping ornon-overlapping) targets or to provide a neuromodulation interventionfor a particular target at different times. The neuromodulationintervention in the multiple targets can be performed in time-dependentmanner (e.g. target 1 occurs first, target 2 next, and so forth).Neuromodulation intervention in the multiple targets may or may notoverlap spatially or temporally.

Targets, or estimated stimulation regions based on stimulationparameters, may be displayed to the user as a static image or as ananimation (e.g. when multiple target volumes are present at multipletimes). The display of targets, or estimated stimulation regions basedon stimulation parameters, may be based on any type of construct, suchas, for example, an electrical potential distribution, electric field,divergence of electric field (activating function), the Hermitian of theactivating function, a Volume of Activation (VOA) model, or aStimulation Field Model (SFM) or the like which considers the effects ofthe neuromodulation intervention on active neural elements in the targetand deterministically quantifies the effect, allowing for the display ofcontinuous (e.g. threshold) or discrete (e.g. binary fire/no-fire) data.Targets, or estimated stimulation regions based on stimulationparameters, may be displayed as 2D contours or 3D surfaces at a varietyof thresholds (for example, electrical potential, electrical field, orthe like which could be chosen by the user or method) or planar cutawayswith overlayed false color maps. Different targets, or estimatedstimulation regions based on stimulation parameters, may bedistinguished by, for example, color, texture, luminosity, or the like.

In at least some embodiments, the user can modify the previouslyidentified set of stimulation parameters. In at least some embodiments,an estimated stimulation region can be displayed based on the modifiedstimulation parameters.

In an alternative to the methods illustrated in FIGS. 4 and 5, after theuser or system selects one or more targets, the system or the user canengage in a steering technique to select the stimulation parameters.FIG. 7 is a flowchart of one method of steering a set of initialstimulation parameters in order to obtain a set of final stimulationparameters. In step 702 an initial set of stimulation parameters isprovided. The set can be provided in any manner including using any ofthe methods described above. Alternatively, the set of initialstimulation parameters can selected using any other technique.Optionally, a GUI can display a representation of the field generatedusing these parameters, a volume of activation or stimulation generatedusing these parameters, or a lead graphically or alphanumericallypresenting the parameters, or any other representation, or anycombination of these representations. In other embodiments, there is nographical representation of the lead or region of stimulation.

In step 704, the user provides an alphanumeric command to alter one ormore of the stimulation parameters. In at least some embodiments, thiscommand does not include, or is not composed exclusively of, a numericalvalue for any of the stimulation parameters. This command can includeone or more words that direct modification of the stimulation parametersto obtain the goal recited in the command. Examples of such wordsinclude, but are not limited to, ‘up’, ‘down’, ‘left’, ‘right’,‘clockwise’, ‘counter-clockwise’, ‘spread’, ‘focus’, ‘faster’, ‘slower’,‘longer’, ‘shorter’, and so forth. These commands are abstract steeringcontrols that can affect, for example, the number or selection of activeelectrodes, the polarity and amplitude of the electrodes, pulse width,frequency, amplitude, inter-pulse interval, regularity, and the like ofthe stimulation.

In optional step 706, the modification of the stimulation parameters isobserved. In some embodiments, the modification can be observed, forexample, by a change in a display of the representation of the fieldgenerated using these parameters or a volume of activation or a volumeof stimulation generated using these parameters. In some embodiments,the modification can be observed as a stimulation effect or side effectthat is noted by the user or patient. The user or patient may provide arating of the stimulation parameters.

In step 708, the modification and observation steps (steps 704 and 706)can be repeated to perform further modifications of the stimulationparameters. This process can continue until a final set of stimulationparameters is obtained.

FIG. 8 is a flowchart of one method of steering a set of initialstimulation parameters in order to obtain a set of final stimulationparameters. In step 802 an initial set of stimulation parameters isprovided. The set can be provided in any manner including using any ofthe methods described above. Alternatively, the set of initialstimulation parameters can selected using any other technique. A GUIdisplays a representation of the field generated using these parameters,a volume of activation or stimulation generated using these parameters,or a lead graphically or alphanumerically presenting the parameters, orany other representation, or any combination of these representations.

Using a graphical interface, in step 802 the user modifies thestimulation parameters. For example, the interface can includecomponents for selecting which electrodes to activate; components forraising or lowering parameters such as amplitude, frequency, pulsewidth, or the length; and so forth. In other embodiments, the interfacemay permit the user to modify the field or volume of activationgenerated using the parameters and then the system can calculate the newset of stimulation parameters based on the modified field or volume.

In optional step 806, the modification of the stimulation parameters isobserved. In some embodiments, the modification can be observed, forexample, a change in a display of the representation of the fieldgenerated using these parameters or a volume of activation or a volumeof stimulation generated using these parameters. In some embodiments,the modification can be observed as a stimulation effect or side effectthat is noted by the user or patient. The user or patient may provide arating of the stimulation parameters.

In step 808, the modification and observation steps (steps 804 and 806)can be repeated to perform further modifications of the stimulationparameters. This process can continue until a final set of stimulationparameters is obtained.

In at least some embodiments of a method of selecting stimulationparameters, a coarse exploration of the parameter space is made withabstracted steering controls (such as the methods in FIG. 7 or 8), andthen a targeting method (such as the methods of FIG. 4 or 5) predicts aset of stimulation parameters for the target, and then a subsequent passwith steering controls is made. This process can be iterated. It hasalso been found that in some steering methods, if the current or fieldis steered from one combination of electrodes to a differentcombination, or from a combination of electrodes to a single electrode(or vice versa), certain descriptive parameters may change, for example,the radius of the volume of tissue activated, the cumulative rateexperienced, the total power injected, or the like. For example,steering a current or field from two electrodes A and B to a singleelectrode B may increase the radius of the area of stimulation. Thesystem can be arranged to account for this and, instead, maintain theradius of the area of stimulation constant by modifying the stimulationparameters accordingly. The system can be configured to maintain one ormore characteristics constant, or to adjust them as parameters areadjusted.

FIGS. 9A and 9B illustrate another method of identifying a target usinga lead 902 and target point 907 from two orthogonal views. (FIGS. 9A and9B also illustrate an axis indicator 905.) The user or system places thetarget point 907. The system projects back a line 909 from the targetpoint 907 to the surface of the lead 902. In some embodiments, the line909 can be a minimum distance line from the target point 907 to thesurface of the lead 902. At the intersection of the lead and thisprojected line, a point source 911 is identified. This point source 911can be used to model a monopolar point source (for example, cathodic)field. Other virtual electrical elements may be employed instead of apoint source, such as a combination of point sources or a virtualelectrode having some other form than the real electrodes on the lead.Alternatively, closed form solutions to approximating electrodes may beused. The virtual electrode or electrodes may, or may at times, take theform and position of one or more electrodes in the real electrode array.The user may select the boundaries of the virtual electrode or thesystem can determine boundaries which are optionally user-adjustable.Although a point source will be used below for illustrative purposes, itwill be understood that a combination of point sources or a virtualelectrode can be used instead of the point source.

FIG. 10 illustrates one embodiment of a point source 911 on a lead 902.In this embodiment, when calculating the potential field 913 for eachpoint source 911, only the region not overlapping the lead, bounded bythe plane tangent to the lead at the point is used. In this calculation,the current only contributing to ½ of the volume is considered so doublethe current I used to calculate the current at each point V(r)=2I/4πrσwhere r is the distance from the point source and σ is the conductivity.In other embodiments, the solution for a point source on the exterior ofan insulating rod may be used.

The system then uses the extant electrodes 934 of the lead 902 todetermine a best-fit (for example, using a least squares calculation) tothis point source field by activating the electrodes using a set ofstimulation parameters to approximate the point source field. The pointsource field may be a scalar potential field, a vector field (forexample, an electric field, or divergence of the electric field), or afield of Hamiltonians of the divergence of the electric field, or thelike. In some embodiments, the user can modify the resulting stimulationparameters to modify the field. For example, the user may ‘focus’ or‘spread’ the field radially or longitudinally. In at least someembodiments, radial focus can involve the addition of anodes antipodalto the target point.

In another embodiment, the target electric field may be computed fromcombinations of pre-computed basis fields, or by the combination ofsolutions of analytic fits to pre-computed data.

Instead of designating a target point, a user can alternativelydesignate a virtual electrode and use this electrode to generatestimulation. The system can then select stimulation parameters using theactual electrodes of the lead to approximate the virtual electrode. FIG.11 illustrates a lead 1102 with electrodes 1134. The user can place andedit a virtual electrode 1135 on the surface of the lead 1132. Thevirtual electrode 1135 can have any desired shape (for example, circle,rectangle, triangle, or the like) which can be curved, if desired, oreven form a ring around the lead. Typically, the virtual electrode islimited to the span of the electrode array.

In some embodiments, edges or segments of edges of the virtual electrodecan be set to ‘guard’ to reduce or prevent extending the field generatedby the virtual electrode beyond the edges. For example, if the virtualelectrode is a cathode, the guarded edges can provide anodic guarding.In at least some embodiments, the strength of guarding can be set,independently for each edge or segment. FIG. 12 illustrates anodicguarding handled by creating one or more virtual guarding electrodes1137, one for each edge of the virtual electrode 1135 of the lead 1102which is guarded, and moving them closer or strengthening them as theuser increases the level of guarding.

In any of the systems and methods described above, when a set ofstimulation parameters is determined, the set of stimulation parameterscan be communicated to an IPG, ETS, or other device.

It will be understood that the system can include one or more of themethods described hereinabove with respect to FIGS. 4-12 in anycombination. The methods, systems, and units described herein may beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein. Accordingly, the methods, systems,and units described herein may take the form of an entirely hardwareembodiment, an entirely software embodiment or an embodiment combiningsoftware and hardware aspects. The methods described herein can beperformed using any type of processor or any combination of processorswhere each processor performs at least part of the process.

It will be understood that each block of the flowchart illustrations,and combinations of blocks in the flowchart illustrations and methodsdisclosed herein, can be implemented by computer program instructions.These program instructions may be provided to a processor to produce amachine, such that the instructions, which execute on the processor,create means for implementing the actions specified in the flowchartblock or blocks disclosed herein. The computer program instructions maybe executed by a processor to cause a series of operational steps to beperformed by the processor to produce a computer implemented process.The computer program instructions may also cause at least some of theoperational steps to be performed in parallel. Moreover, some of thesteps may also be performed across more than one processor, such asmight arise in a multi-processor computer system. In addition, one ormore processes may also be performed concurrently with other processes,or even in a different sequence than illustrated without departing fromthe scope or spirit of the invention.

The computer program instructions can be stored on any suitablecomputer-readable medium including, but not limited to, RAM, ROM,EEPROM, flash memory or other memory technology, CD-ROM, digitalversatile disks (“DVD”) or other optical storage, magnetic cassettes,magnetic tape, magnetic disk storage or other magnetic storage devices,or any other medium which can be used to store the desired informationand which can be accessed by a computing device.

The above specification provides a description of the structure,manufacture, and use of the invention. Since many embodiments of theinvention can be made without departing from the spirit and scope of theinvention, the invention also resides in the claims hereinafterappended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A system for identifying a set of stimulationparameters, the system comprising: a computer processor configured andarranged to perform the following actions: receiving, as a first inputfrom a user, a name of a disease or disorder; receiving, as a secondinput from the user, a clinical goal; after receiving both the firstinput and the second input and using both 1) the disease or disorder and2) the clinical goal, selecting, by the computer processor withoutfurther user intervention, the set of stimulation parameters; andcommunicating the set of stimulation parameters to an implantable pulsegenerator to stimulate a patient using the set of stimulationparameters.
 2. The system of claim 1, further comprising receiving, as athird input from the user, a system goal, wherein selecting the set ofstimulation parameters comprises using the system goal to select the setof stimulation parameters.
 3. The system of claim 2, wherein the systemgoal refers to one or more components of an electrical stimulationsystem or to one or more stimulation parameters and also refers to anobjective related to the one or more components or stimulationparameters.
 4. The system of claim 1, wherein the clinical goal refersto a symptom of the disease or disorder or to an effect or side effectassociated with the disease or disorder.
 5. The system of claim 1,wherein the actions further comprise receiving, as a third input fromthe user, a user modification of at least one of the stimulationparameters.
 6. The system of claim 1, wherein selecting the set ofstimulation parameters further comprises using previous stimulationinstances or estimated stimulation instances to select the set ofstimulation parameters.
 7. The system of claim 1, wherein the actionsfurther comprise displaying an estimated stimulation region based on theselected set of stimulation parameters.
 8. The system of claim 1,wherein the actions further comprise receiving, as a third input fromthe user, a command to alter the set of stimulation parameters, whereinthe command does not include a numerical value for any of thestimulation parameters; and modifying the set of stimulation parametersto create a modified set of stimulation parameters based on the command.9. The system of claim 1, wherein the actions further comprisereceiving, as a third input from the user, a command to alter the set ofstimulation parameters, wherein the command is not composed exclusivelyof a numerical value for any of the stimulation parameters; andmodifying the set of stimulation parameters to create a modified set ofstimulation parameters based on the command.
 10. The system of claim 8wherein the actions further comprise displaying an estimated stimulationregion based on the selected set of stimulation parameters; and uponmodification of the set of stimulation parameters to create the modifiedset of stimulation parameters, modifying the display to display anestimated stimulation region based on the modified set of stimulationparameters.
 11. The system of claim 1, wherein receiving the clinicalgoal comprises receiving, as the second input from the user, theclinical goal as a verb/noun combination.
 12. The system of claim 1,wherein receiving the name of the disease or disorder comprisesselecting, by input from the user, the name of the disease or disorderfrom a list.
 13. The system of claim 1, wherein receiving the name ofthe disease or disorder comprises receiving the name of the disease ordisorder and also receiving a name of an anatomical or physiologicaltarget associated with the disease or disorder.
 14. The system of claim13, wherein receiving the name of the disease or disorder comprisesselecting, by input from the user, the name of the disease or disorderfrom a list that is based on the previously received name of theanatomical or physiological target.
 15. The system of claim 13, whereinreceiving the name of the anatomical or physiological target comprisesselecting, by input from the user, the name of the anatomical orphysiological target from a list that is based on the previouslyreceived name of the disease or disorder.
 16. The system of claim 1,wherein receiving the clinical goal comprises selecting, by input fromthe user, the clinical goal from a list that is based on the previouslyreceived name of the disease or disorder.
 17. The system of claim 1,further comprising an implantable pulse generator configured to receivethe set of stimulation parameters from the computer processor and tostimulate the patient using the set of stimulation parameters.
 18. Thesystem of claim 17, further comprising a lead comprising a plurality ofelectrodes coupleable to the implantable pulse generator for deliveringthe stimulation to the patient.
 19. A non-transitory computer-readablemedium having instructions thereon for performing, by a computerprocessor, a method for identifying a set of stimulation parameters, themethod comprising: receiving, as a first input from a user, a name of adisease or disorder; receiving, as a second input from the user, aclinical goal; after receiving both the first input and the second inputand using both 1) the disease or disorder and 2) the clinical goal,selecting, by the computer processor without further user intervention,the set of stimulation parameters; and communicating the set ofstimulation parameters to an implantable pulse generator to stimulate apatient using the set of stimulation parameters.